Status:
UNKNOWN
A Study Comparing Two Different Capsules, APL-101 and PLB-1001 Capsules, in Healthy Chinese and Caucasian Participants
Lead Sponsor:
Apollomics Inc.
Conditions:
Bioequivalence
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, open-label, multi-center, randomized, 2-period, adaptive design, crossover study to assess the bioequivalence of APL-101 (Vebreltinib) capsules and PLB-1001 (Bozitinib) capsules. T...
Detailed Description
Up to 48 healthy male subjects (approximately 16 Chinese and approximately 32 Caucasians) will be enrolled in the study in at least 2 sequential cohorts and randomly assigned to 1 of 2 treatment seque...
Eligibility Criteria
Inclusion
- Major
- Must be Chinese (1st generation or 2nd generation Chinese with both Chinese parents), or Caucasian.
- Body mass index between 18.0 and 30.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and at check-in as assessed by the Investigator (or designee). Screening clinical laboratory evaluations may be repeated once at the discretion of the Investigator.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 × the upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN at screening and check-in. Subjects with ALT or AST \>1.0 × ULN combined with total bilirubin \>1.0 × ULN are excluded.
- QT interval corrected for heart rate using Fridericia's method (QTcF) ≤ 450 msec confirmed by calculating the mean of the triplicate measurements within 4 weeks prior to Day 1.
- Systolic blood pressure between 100 and 140 mmHg or diastolic blood pressure between 50 and 90 mmHg, confirmed by calculating the mean of the triplicate measurements within 4 weeks prior to Day 1.
- Major
Exclusion
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
- Have positive Coronavirus Disease 2019 (COVID-19) test at screening and/or at check-in, have clinical signs or symptoms of COVID-19 as determined by the Investigator, or have ongoing significant complication(s) from prior COVID-19 infection.
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 14 days prior to check in, unless deemed acceptable by the Investigator.
- Have previously completed or withdrawn from this study or any other study investigating APL 101 or similar drug product, and/or have previously received APL 101 or similar drug product.
Key Trial Info
Start Date :
May 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05367388
Start Date
May 20 2022
End Date
December 1 2022
Last Update
June 15 2022
Active Locations (1)
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1
New Zealand Clinical Research
Auckland, New Zealand